Use of Patented Inventions after FDA Approval: How to Define the Hatch-Waxman Safe Harbor in Light of Momenta and Classen

By: Madeline Schiesser

Abstract: This paper will discuss the apparent inconsistencies in the recent Classen v. Biogen and Momenta v. Amphastar decisions by the Court of Appeals for the Federal Circuit regarding the Hatch-Waxman Safe Harbor. Although it is well settled that the Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act permits a generic drug company to use the patented invention of another party to develop a generic drug for approval by the United States Food and Drug Administration (“FDA”), the court’s recent decisions have raised a question as to whether the safe harbor may protect activity subsequent to FDA approval of the generic drug. Clarification is needed on this issue and should to be provided forthwith by the judiciary. Without judicial guidance, the institutions responsible for the development and financial support of new and generic pharmaceuticals will be plagued by both legal and business uncertainty, which will adversely affect all stakeholders, including patentees, generic drug companies, and consumers.

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